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Nucleos(t)ide analogue

RO7565020 for Chronic Hepatitis B

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 104 weeks

Awards & highlights

Study Summary

This trial tests a new drug for safety and effectiveness in people with chronic Hepatitis B.

Who is the study for?

This trial is for healthy adults or those with chronic hepatitis B (CHB) who have a BMI of 18-32 kg/m^2. CHB participants must have been positive for HBsAg for at least 6 months and on NUC therapy for over a year without signs of advanced liver disease. People with cirrhosis, suspected cancer, or other significant diseases are excluded.Check my eligibility

What is being tested?

The study tests RO7565020's safety and effects in humans compared to a placebo. It's the first time this drug is being tried in people. The trial will gradually increase doses to find safe levels and see how the body reacts over single or multiple doses in both healthy individuals and those with suppressed CHB.See study design

What are the potential side effects?

Since this is an early-phase trial, specific side effects of RO7565020 aren't fully known yet. However, potential risks may include reactions at the injection site, flu-like symptoms, nausea, fatigue, headache, and possible liver-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Healthy Volunteers With Adverse Events

Percentage of Participants With Chronic Hepatitis B With Adverse Events

Secondary outcome measures

Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)

Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints

Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RO7565020Experimental Treatment2 Interventions

Group II: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,051 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,768 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of a certain age precluded from this research protocol?

"This clinical trial is bringing on adult participants aged 18 to 65 years."

Answered by AI

How many participants have been recruited into this clinical investigation?

"Affirmative. The clinicaltrials.gov database reveals that the study, which was first posted on April 28th 2023, is still recruiting participants. 110 volunteers are needed at 3 separate locations for this medical trial."

Answered by AI

Is RO7565020 a secure drug to take for individuals?

"Due to the limited prior clinical data available, RO7565020 was allocated a score of 1 for safety. This is in line with expectations as this Phase 1 trial will assess both efficacy and safety."

Answered by AI

Are there any remaining opportunities to join this research endeavor?

"According to the details on clinicaltrials.gov, this trial is currently enlisting applicants and was initially declared on April 28th 2023, with the most recent update taking place on October 5th 2023."

Answered by AI

Am I eligible to be a part of this research endeavor?

"This clinical trial seeks 110 individuals who suffer from chronic hepatitis b, and are aged 18-65. Additionally, they must be deemed healthy by medical professionals, have a BMI between 18 & 32 kg/m^2, been on NUC monotherapy for 12+ months and had recent liver biopsy or FibroScan evidence of HBV infection without fibrosis or cirrhosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

2023. "A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05763576.

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